Implantation of flexible implant

ABSTRACT

Apparatus is provided for repairing a cardiac valve, the apparatus can include a flexible annuloplasty structure having a sleeve with an elongated tubular side wall and a distal tip. A first tissue anchor can passing through the distal tip of the sleeve, and a second tissue anchor can pass through a section of the tubular side wall. The first and second tissue anchors can extend in a substantially same direction. A longitudinal portion of the tubular side wall can be disposed between the first and second tissue anchors, and have a first lateral part opposite a second lateral part and closer to the first and second tissue anchors than the second lateral part is to the first and second tissue anchors. The second lateral part can have a degree of tension that is larger than a degree of tension of the first lateral part.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application of U.S. Ser. No.15/444,862 to Zipory et al., entitled, “Implantation of flexibleimplant,” filed on Feb. 28, 2017, which published as US 2017/0196691 andwhich is a continuation application of U.S. Ser. No. 14/141,228 toZipory et al., entitled, “Implantation of flexible implant,” filed onDec. 26, 2013, which issued as U.S. Pat. No. 9,610,162. The aboveapplications and patents are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair, and morespecifically to repair of an atrioventricular valve of a patient.

BACKGROUND OF THE INVENTION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

SUMMARY OF THE INVENTION

In some embodiments of the present invention, an adjustable annuloplastystructure is provided for repairing a dilated valve annulus of anatrioventricular valve, such as a mitral valve. The annuloplastystructure comprises a flexible sleeve and a plurality of anchors. Ananchor deployment manipulator is advanced into a lumen of the sleeve,and, from within the lumen, deploys the anchors through a wall of thesleeve and into cardiac tissue, thereby anchoring the sleeve around aportion of the valve annulus. The anchors are typically deployed from adistal end of the manipulator while the distal end is positioned suchthat a central longitudinal axis through the distal end of themanipulator forms an angle with a surface of the cardiac tissue ofbetween about 20 and 90 degrees, e.g., between about 45 and 90 degrees,e.g., between about 75 and 90 degrees, such as about 90 degrees.Typically, the anchors are deployed from the distal end of themanipulator into the cardiac tissue in a direction parallel to thecentral longitudinal axis through the distal end of the manipulator.

A multi-component tubular system is provided for accessing a heart of apatient. The system comprises one or more steerable guiding cathetersconfigured for directing the passage of devices therethrough into theheart. The multi-component tubular system is configured to deliver animplant in a desired orientation to an annulus of a cardiac valve of thepatient and to facilitate anchoring of the implant to the annulus. Forsome applications of the present invention, the guiding system isadvanced transluminally or transthoracically accessing an atrium of theheart. Typically, the system comprises two or more steerable catheters.A first catheter has a distal portion that is steerable to a firstdesired spatial orientation. A second catheter is disposed within thefirst catheter and has a distal portion that is steerable to a seconddesired spatial orientation.

Typically, the annuloplasty structure comprises a sleeve with anelongated tubular wall and at least one end wall having a surfacesubstantially transverse to a lateral surface of the tubular wall. Amethod is provided for deploying a first tissue anchor through thesurface of the end wall of the sleeve and into annulus tissue andsubsequently deploying a second tissue anchor through the tubular wall.The first tissue anchor and the second tissue anchor are both deployedconsecutively to extend in a substantially same direction and into acommon, substantially planar surface of a valve annulus. That is, thefirst and second tissue anchors are deployed in succession with nointervening anchor between the anchors, and a distance between theanchors is between 2.5 and 15 mm, e.g., between 2.5 and 9 mm, e.g., 8mm.

The first and second anchors extend in the substantially same directiondespite that the first tissue anchor is deployed through the end walltransverse to the side wall. That is, the first and second anchorsextend in the substantially same direction while the first tissue anchoris deployed through the end wall transverse to the side wall.

In such a deployment, a distal end portion of the sleeve between thefirst and second tissue anchors is formed into a substantial “U”-shapedportion having a concavity facing the tissue of the annulus.

There is therefore provided, in accordance with some applications of thepresent invention, a method of deploying an annuloplasty structure, themethod including:

introducing into a heart atrium, the annuloplasty structure having asleeve with an elongated tubular side wall and at least one distal endwall having a surface substantially transverse to a lateral surface ofthe tubular side wall;

deploying a first tissue anchor through the surface of the end wall ofthe sleeve and into a first portion of annulus tissue; and

deploying a second tissue anchor through a portion of the tubular sidewall and into a second portion of annulus tissue, such that the firsttissue anchor and the second tissue anchor are both deployedconsecutively, to extend in a substantially same direction and into acommon, substantially planar surface of a valve annulus, the common,substantially planar surface including the first and second portions ofthe annulus tissue.

In some applications of the present invention, deploying the secondtissue anchor includes deploying the second tissue anchor between 2.5and 15 mm from the first tissue anchor.

In some applications of the present invention, deploying the secondtissue anchor includes deploying the second tissue anchor between 2.5and 9 mm from the first tissue anchor.

In some applications of the present invention, deploying the secondtissue anchor through the tubular wall includes deploying the secondtissue anchor substantially parallel with respect to the first tissueanchor.

In some applications of the present invention, deploying the secondtissue anchor through the tubular wall includes deploying the secondtissue anchor between 0 and 45 degrees with respect to the first tissueanchor.

In some applications of the present invention, deploying the secondtissue anchor through the tubular wall, includes deploying the secondtissue anchor between 0 and 20 degrees with respect to the first tissueanchor.

In some applications of the present invention, deploying the secondtissue anchor includes forming a portion of the sleeve between the firstand second tissue anchors into a substantially “U”-shaped portion.

In some applications of the present invention, deploying the firstanchor includes deploying the first anchor from a distal end of adeployment manipulator through the surface of the end wall of the sleeveinto the cardiac tissue, while the distal end of the deploymentmanipulator is positioned such that a central longitudinal axis throughthe distal end of the deployment manipulator forms an angle of between20 and 90 degrees with the distal end wall of the sleeve at a point atwhich the first anchor penetrates the end wall.

In some applications of the present invention, deploying the firstanchor includes deploying the first anchor from a distal end of adeployment manipulator through the surface of the end wall of the sleeveinto the cardiac tissue, while the distal end of the deploymentmanipulator is positioned such that a central longitudinal axis throughthe distal end of the deployment manipulator forms an angle of between45 and 90 degrees with the distal end wall of the sleeve at a point atwhich the first anchor penetrates the end wall.

In some applications of the present invention, deploying the secondanchor includes deploying the second anchor from a distal end of adeployment manipulator through the surface of the portion of the tubularwall of the sleeve into the cardiac tissue, while the distal end of thedeployment manipulator is positioned such that a central longitudinalaxis through the distal end of the deployment manipulator forms an angleof between 20 and 90 degrees with the portion of the tubular wall of thesleeve at a point at which the second anchor penetrates the portion ofthe tubular wall.

In some applications of the present invention, deploying the secondanchor includes deploying the second anchor from a distal end of adeployment manipulator through the surface of the portion of the tubularwall of the sleeve into the cardiac tissue, while the distal end of thedeployment manipulator is positioned such that a central longitudinalaxis through the distal end of the deployment manipulator forms an angleof between 45 and 90 degrees with the portion of the tubular wall of thesleeve at a point at which the second anchor penetrates the portion ofthe tubular wall.

In some applications of the present invention, deploying the firstanchor includes deploying the first anchor through a channel disposedwithin a lumen of the sleeve, the channel having a distal end definingan opening through with the first anchor passes, and deploying the firstanchor includes sandwiching the surface of the end wall of the sleevebetween the distal end of the channel and the first portion of annulustissue.

In some applications of the present invention, sandwiching includespositioning the distal end of the channel in a manner in which thedistal end of the channel is aligned substantially parallel to theplanar surface.

In some applications of the present invention, deploying the secondanchor includes deploying the second anchor through a channel disposedwithin a lumen of the sleeve, the channel having a distal end definingan opening through with the second anchor passes, and deploying thesecond anchor includes sandwiching the portion of the tubular side wallof the sleeve between the distal end of the channel and the secondportion of annulus tissue.

In some applications of the present invention, sandwiching includespositioning the distal end of the channel in a manner in which thedistal end of the channel is aligned substantially parallel to theplanar surface.

In some applications of the present invention, the method furtherincludes, following the deploying the first tissue anchor, flexing theannuloplasty structure while the distal end wall is anchored, to form aportion of the sleeve that is proximal to the distal end into asubstantially “U”-shaped portion.

In some applications of the present invention, deploying the secondtissue anchor includes forming a portion of the sleeve between the firstand second tissue anchors into an arc with a concave surface facing theannulus tissue.

In some applications of the present invention, the method furtherincludes forming a distal portion of the sleeve between the first andsecond tissue anchors into a shape.

In some applications of the present invention, forming the distalportion of the sleeve into the shape includes forming the distal portionof the sleeve into the shape prior to the deploying of the second anchorby flexing the distal portion of the sleeve.

In some applications of the present invention, forming the distalportion of the sleeve into the shape includes forming the distal portionof the sleeve into the shape responsively to the deploying of the secondanchor.

In some applications of the present invention, the annuloplastystructure includes a stiffener configured to bias the annuloplastystructure into the shape.

In some applications of the present invention, forming the distalportion of the sleeve into the shape includes forming the distal portionof the sleeve into a shape in which:

a first part of the lateral surface of the tubular side wall ispositioned close to the tissue of the annulus,

a second part of the lateral surface of the tubular side wall isdisposed opposite the first part of the lateral surface of the tubularside wall and away from the tissue of the annulus, and

the second part of the lateral surface of the tubular side wall has adegree of tension that is larger than a degree of tension of the firstpart of the lateral surface of the tubular side.

In some applications of the present invention, the first part of thelateral surface of the tubular side wall is ruffled and is disposedadjacent the tissue of the annulus.

In some applications of the present invention, forming the distalportion of the sleeve into the shape includes forming the distal portionof the sleeve into a shape having a concavity.

In some applications of the present invention, forming the distalportion of the sleeve into the shape having the concavity includescreating a gap between the distal portion of the sleeve and the annulustissue, the gap having a longest distance between 0.2 and 7.5 mm.

In some applications of the present invention, forming the portion ofthe sleeve into the shape having the concavity includes creating a gapbetween the portion and the annulus tissue, the gap having a longestdistance between 0.5 and 3 mm.

In some applications of the present invention, the method furtherincludes, following the deploying the first tissue anchor, flexing theannuloplasty structure while the distal end wall is anchored, to form aconcave shape of the structure between (a) a portion of the structureproximal to the distal end wall of the structure, and (b) the annulus,deploying the second tissue anchor includes maintaining the concaveshape during the deploying.

In some applications of the present invention, deploying the firsttissue anchor and deploying the second tissue anchor includes deployingthe first and second tissue anchors from within a lumen of a channeldisposed within a lumen of the sleeve while at least a proximal portionof the sleeve is surrounded by a catheter.

In some applications of the present invention, the valve is a mitralvalve.

There is also provided, in accordance with some applications of thepresent invention, a method of repairing a cardiac valve, the methodincluding:

introducing into a heart atrium, a flexible annuloplasty structurehaving a sleeve with an elongated tubular side wall and at least onedistal end wall having a surface substantially transverse to a lateralsurface of the tubular side wall;

anchoring the distal end wall of the sleeve to a valve annulus on anatrial surface of the valve by deploying a first tissue anchor;

while the distal end wall is anchored, positioning alongside the valveannulus a portion of the tubular side wall that is proximal to thedistal end wall in a manner in which the portion of the tubular sidewall assumes a shape in which:

-   -   a first part of the lateral surface of the tubular side wall is        positioned close to the tissue of the annulus,    -   a second part of the lateral surface of the tubular side wall is        disposed opposite the first part of the lateral surface of the        tubular side wall and away from the tissue of the annulus, and    -   the second part of the lateral surface of the tubular side wall        has a degree of tension that is larger than a degree of tension        of the first part of the lateral surface of the tubular side;

anchoring the portion of the tubular side wall to the annulus bydeploying a second tissue anchor consecutively to the first tissueanchor; and

continuing to position the annuloplasty structure about a circumferenceof the atrial surface of the annulus while periodically anchoringadditional locations of the tubular side wall of the sleeve to theatrial surface of the annulus.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus for repairing a cardiac valve, theapparatus including:

a flexible annuloplasty structure having a sleeve with an elongatedtubular side wall and at least one distal end wall having a surfacesubstantially transverse to a lateral surface of the tubular side wall;

a first tissue anchor passing through the distal end wall of the sleeve;and

a second tissue anchor passing through the tubular side wall, the firstand second tissue anchors being disposed consecutively and to extend ina substantially same direction.

There is further provided, in accordance with some applications of thepresent invention, apparatus for repairing a cardiac valve, theapparatus including:

a flexible annuloplasty structure having a sleeve with an elongatedtubular side wall and at least one distal end wall having a surfacesubstantially transverse to a lateral surface of the tubular side wall;

a first tissue anchor passing through the distal end wall of the sleeve;and

a second tissue anchor passing through the tubular side wall in a mannerin which a portion of the tubular side wall that is between the firstand second tissue anchors assumes a shape in which:

-   -   the portion has a first part of the lateral surface of the        tubular side wall and a second part of the lateral surface of        the tubular side wall opposite the first part, and    -   the second part of the lateral surface of the tubular side wall        has a degree of tension that is larger than a degree of tension        of the first part of the lateral surface of the tubular side        wall.

There is yet additionally provided, in accordance with some applicationsof the present invention, a method of repairing a cardiac valve, themethod including:

introducing into a heart atrium, an annuloplasty structure having asleeve with an elongated tubular side wall and at least one distal endwall having a surface substantially transverse to a lateral surface ofthe tubular side wall;

anchoring, using a first tissue anchor, the distal end wall of thesleeve to a valve annulus on an atrial surface of the valve;

forming a concave shape of a distal portion of the structure between thedistal end portion of the structure and the annulus by positioning thetubular side wall in a vicinity of the valve annulus by flexing theannuloplasty structure while the distal end wall is anchored;

anchoring, using a second tissue anchor, a distal portion of the tubularside wall of the sleeve to the annulus, such that when the first tissueanchor and the second tissue anchor are anchored, the concave shape ismaintained along the distal portion of the structure; and

continuing to position the annuloplasty structure about a circumferenceof the atrial surface of the annulus while periodically anchoringadditional locations of the tubular side wall of the sleeve to theatrial surface of the annulus.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an annuloplasty ring structure,comprising a sleeve and an adjusting mechanism, in accordance with someapplications of the invention;

FIG. 2 is a schematic illustration of a multi-component tubular systemfor delivering and anchoring an implant and for controlling a relativespatial orientation of components of the catheter system, in accordancewith some applications of the present invention;

FIGS. 3A-C are schematic illustrations of an annuloplasty ringstructure, comprising a sleeve and an adjusting mechanism, in accordancewith some applications of the invention;

FIGS. 4A-G are schematic illustrations of steps in the implantation ofan annuloplasty ring structure to repair a mitral valve, in accordancewith some applications of the invention;

FIG. 5 is a schematic illustration of a state of a distal portion of amulti-component tubular system within the heart of a subject, inaccordance with some applications of the invention;

FIGS. 6A-C are schematic illustrations of a tissue anchor, in accordancewith some applications of the present invention; and

FIG. 7 is a schematic illustration of a step in the implantation of anannuloplasty ring structure to repair a mitral valve, in accordance withsome applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofa multi-component tubular system 10 providing one or morerotationally-controlled steering catheters configured for delivering animplant to a heart of a patient, in accordance with some applications ofthe present invention.

FIG. 1 shows a distal portion of an implant comprises an annuloplastyring structure 222 (e.g., an annuloplasty band) comprising a flexiblesleeve 26 (shown in the exploded view of FIG. 2). Sleeve 26 typicallycomprises a braided fabric mesh, e.g., comprising DACRON™. Sleeve 26 istypically configured to be placed only partially around a cardiac valveannulus (i.e., to assume a C-shape), and, once anchored in place, to becontracted so as to circumferentially tighten the valve annulus.Alternatively, the ring structure is configured to be placed entirelyaround the valve annulus.

Sleeve 26 has an elongated lateral tubular side wall 253 and at leastone end wall 251 (e.g., a distal end wall) having a surface that issubstantially transverse to a lateral surface of tubular wall 253.Typically, end wall 251 defines an end wall of annuloplasty ringstructure 222.

In order to tighten the annulus, annuloplasty ring structure 222comprises a flexible elongated contracting member 226 that extends alongsleeve 26. Elongated contracting member 226 comprises a wire, a ribbon,a rope, or a band, which typically comprises a flexible and/orsuperelastic material, e.g., nitinol, polyester, stainless steel, orcobalt chrome. For some applications, the wire comprises a radiopaquematerial. For some applications, contracting member 226 comprises abraided polyester suture (e.g., Ticron). For some applications,contracting member 226 is coated with polytetrafluoroethylene (PTFE).For some applications, contracting member 226 comprises a plurality ofwires that are intertwined to form a rope structure.

Annuloplasty ring structure 222 further comprises an adjustmentmechanism 40, which facilitates contracting and expanding ofannuloplasty ring structure 222 so as to facilitate adjusting of aperimeter of the annulus and leaflets of the cardiac valve. Adjustmentmechanism 40 is described in more detail hereinbelow. Adjustmentmechanism 40 comprises a rotatable structure (e.g., a spool, asdescribed hereinbelow) that is disposed within a housing 44. As shown inthe enlarged image of FIG. 1, adjustment mechanism 40 is surrounded by abraided mesh and is coupled (e.g., by being sutured or otherwisecoupled) to the braided mesh of sleeve 26. For some applications,adjustment mechanism 40 is coupled to an outer, lateral surface ofsleeve 26.

Reference is now made to FIG. 2, which shows the concentric relationshipbetween components of tubular system 10 (in an exploded view on the leftside of FIG. 2). System 10 comprises an implant-delivery tool.Typically, system 10 comprises a first, outer catheter 12 comprising asheath configured for advancement through vasculature of a patient. Forsome applications of the present invention, outer catheter 12 comprisesa sheath configured for advancement through a femoral artery toward aninteratrial septum of a heart of a patient. A distal steerable endportion of outer catheter 12 is configured to pass through the septumand be oriented in a desired spatial orientation. System 10 comprises asecond catheter, or guide catheter 14, comprising a steerable distal endportion. Catheter 14 is configured for advancement through a lumen ofouter catheter 12.

A distal end portion of outer catheter 12 is steerable. The distal endportion of outer catheter 12 comprises a pull ring 11 that is coupled totwo or more pull wires 29 a and 29 b, that are disposed withinrespective secondary lumens within a wall of catheter 12 (as shown insection A-A). As shown in the exploded view, guide catheter 14 isconfigured to be concentrically disposed within the lumen of catheter12. As described hereinabove, the distal end portion of guide catheter14 is steerable. The distal end portion of catheter 14 comprises a pullring 13 that is coupled to two or more pull wires 31 a and 31 b, thatare disposed within respective secondary lumens within a wall ofcatheter 14 (as shown in sections A-A and B-B).

Guide catheter 14 is steerable to a desired spatial orientation in orderto facilitate advancing and implantation of an implant in a body cavityof the patient.

For applications in which system 10 is used to deliver an implant to themitral valve of the patient, typically, outer catheter 12 is configuredfor initial advancement through vasculature of the patient until adistal end 102 of catheter 12 is positioned in the left atrium. Thedistal steerable end portion of catheter 12 is then steered such thatdistal end 102 of catheter 12 is positioned in a desired spatialorientation within the left atrium. The steering procedure is typicallyperformed with the aid of imaging, such as fluoroscopy, transesophagealecho, and/or echocardiography. Following the steering of the distal endportion of catheter 12, guide catheter 14 (which houses annuloplastyring structure 222) is advanced through catheter 12 in order tofacilitate delivery and implantation of structure 222 along the annulusof the mitral valve. During the delivery, at least a portion of thesteerable distal end portion of catheter 14 is exposed from distal end102 of catheter 12 and is thus free for steering toward the annulus ofthe mitral valve, as is described hereinbelow.

During delivery of sleeve 26 to the annulus of the cardiac valve, sleeve26 and mechanism 40 are disposed within a lumen of catheter 14 and arealigned longitudinally with a longitudinal lumen of catheter 14. Suchcoupling of mechanism 40 to sleeve 26 allows mechanism 40 to transitionfrom a state in which it is in line with the longitudinal axis ofcatheter 14 (FIG. 2) to a state in which it is disposed alongside sleeve26 (FIG. 3C, shown hereinbelow). The positioning of adjustment mechanism40 alongside a portion of sleeve 26 exposes a driving interface of therotational structure to be accessed by a rotational tool that is guidedtoward adjustment mechanism 40 via a guide member 86.

Reference is again made to FIG. 1. A flexible, longitudinal guide member86 (e.g., a wire) is coupled to a portion of adjustment mechanism 40(e.g., a portion of the rotatable structure, as described hereinbelow).Guide member 86 is configured to facilitate guiding of a rotational toolvia guide member 86 and toward the rotatable structure of adjustmentmechanism 40. Typically, the rotational tool is configured to engage therotatable structure of adjustment mechanism 40 following implantation ofsleeve 26 along the annulus of the cardiac valve. Guide member 86 passesfrom adjustment mechanism 40, alongside a portion of the distal endportion of guide catheter 14, and into a secondary lumen in the wall ofguide catheter 14, through an opening 15 in guide catheter 14. Guidemember 86 passes through the secondary lumen of guide catheter 14 (asshown in sections A-A and B-B in FIG. 2) and has a proximal end that isaccessible from outside the body of the patient. The secondary lumen inthe wall of guide catheter 14 facilitates passage of guide member 86through system 10 without interfering with the otherconcentrically-disposed elongate tubular members that passconcentrically through the lumen of guide catheter 14.

Reference is again made to FIG. 2. In addition, system 10 comprises aplurality of anchors 32, typically between about 5 and about 20 anchors,such as about 10 or about 16 anchors. Each anchor 32 comprises a tissuecoupling element 60 (e.g., a helical tissue coupling element), and atool-engaging head 62 (e.g., a non-helically-shaped portion), fixed toone end of the tissue coupling element. Only one anchor 32 is shown inFIG. 2 as being reversibly coupled to a deployment element 38 of arotating anchor driver 36 of an anchor deployment manipulator 61. Whensleeve 26 is disposed along the annulus of the cardiac valve, deploymentmanipulator 61 is configured to advance within a lumen of sleeve 26 anddeploy each anchor 32 from within sleeve 26 through a wall of sleeve 26and into cardiac tissue, thereby anchoring sleeve 26 around a portion ofthe valve annulus. The insertion of the anchors into the sleeve anddeployment of the anchors into cardiac tissue is described in detailhereinbelow.

Typically, but not necessarily, anchors 32 comprise a biocompatiblematerial such as stainless steel 316 LVM. For some applications, anchors32 comprise nitinol. For some applications, anchors 32 are coated fullyor partially with a non-conductive material.

Deployment manipulator 61 comprises anchor driver 36 and deploymentelement 38. For some applications, deployment manipulator 61 compriseschannel 18.

As shown in the exploded view of FIG. 2, sleeve 26 is disposed within alumen of guide catheter 14. A force is applied to a proximal end ofsleeve 26 is by a distal end of a reference-force tube 19. As shown, animplant-decoupling channel 18 is advanceable within a lumen ofreference-force tube 19 and through a lumen of sleeve 26. As shown inthe enlarged image of FIG. 1, a distal end 17 of implant-decouplingchannel 18 is disposed in contact with an inner wall of sleeve 26 at adistal end thereof. Additionally, a distal end portion of channel 18comprises a radiopaque marker 1018. As shown, tube 19 and sleeve 26 arelongitudinally and coaxially disposed with respect to each other.

For some applications, channel 18 is steerable.

Typically, manipulator 61 advances within channel 18. For someapplications, system 10 comprises a plurality of anchor drivers 36 ofmanipulator 61, each driver 36 being coupled to a respective anchor 32.Each driver 36 is advanced within channel 18 in order to advance andimplant anchor 32 in tissue. Following implantation of anchor 32, anchor32 is decoupled from driver 36, as described herein, and driver 36 isremoved from within channel 18. Subsequently, a new driver 36 coupled toanother anchor 32 is then advanced within channel 18.

As will be described hereinbelow, a first one of anchors 32 isconfigured to be deployed through end wall 251 of sleeve 26 into cardiactissue, when sleeve 26 is positioned along the annulus of the valve.Following the deployment of the first tissue anchor, a distal portion ofsleeve 26 is slid distally off a portion of implant-decoupling channel18. In order to decouple sleeve 26 distally from a portion of outersurface of channel 18, (1) a proximal force is applied to channel 18,while (2) reference-force tube 19 is maintained in place in a manner inwhich a distal end of tube 19 provides a reference force to sleeve 26 inorder to facilitate freeing of a successive portion of sleeve 26 fromaround channel 18. Channel 18 is then positioned at a successivelocation within the lumen of sleeve 26 while either tube 19 and/orcatheter 14 is steered toward a successive location along the annulus ofthe valve (as will be described hereinbelow). Consequently, thesuccessive portion of sleeve 26 provides a free lumen for advancement ofa successive anchor 32 and deployment of the anchor through the wall ofthe sleeve at the successive portion thereof. Such freeing of thesuccessive portion of sleeve 26 creates a distance between successiveanchors deployed from within the lumen of sleeve 26.

For some applications, sleeve 26 comprises a plurality of radiopaquemarkers 25, which are positioned along the sleeve at respectivelongitudinal sites. The markers may provide an indication in aradiographic image (such as a fluoroscopy image) of how much of thesleeve has been deployed at any given point during an implantationprocedure, in order to enable setting a desired distance between anchors32 along the sleeve. For some applications, the markers comprise aradiopaque ink.

Typically, at least a portion (e.g., at least three, such as all) of thelongitudinal sites are longitudinally spaced at a constant interval.Typically, the longitudinal distance between the distal edges ofadjacent/consecutive markers, and/or the distance between the proximaledges of adjacent markers, is set equal to the desired distance betweenadjacent anchors. For example, the markers may comprise first, second,and third markers, which first and second markers are adjacent, andwhich second and third markers are adjacent, and the distance betweenthe proximal and/or distal edges of the first and second markers equalthe corresponding distance between the proximal and/or distal edges ofthe second and third markers. For example, the distance may be between 3and 15 mm, such as 6 mm, and the longitudinal length of each marker maybe between 0.1 and 14 mm, such as 2 mm (If, for example, the distancewere 6 mm and the length were 2 mm, the longitudinal gaps betweenadjacent markers would have lengths of 4 mm.)

Each anchor 32 is coupled to deployment element 38 of anchor driver 36.Anchor driver 36 comprises an elongate tube having at least a flexibledistal end portion. The elongate tube of driver 36 extends within alumen of channel 18, through system 10 toward a proximal end of aproximal handle portion 101 of system 10. The tube of anchor driver 36provides a lumen for slidable advancement therethrough of an elongaterod 130. Rod 130 facilitates the locking and unlocking of anchor 32 todeployment element 38. As shown in Section E-E of FIG. 2, a proximal endof rod 130 is coupled to a component of an anchor-release mechanism 28at a proximal end of system 10. Mechanism 28 comprises a housing 135 anda finger-engager 131 that is coupled to the proximal end of rod 130.Finger-engager 131 is coupled to a housing 135 via a spring 133 (sectionE-E of FIG. 2). A proximal end of the tube of anchor driver 36 iscoupled to housing 135. As is described hereinbelow, the physicianreleases anchor 32 from deployment element 38 when finger-engager 131 ispulled proximally, thereby pulling rod 130 proximally.

Proximal handle portion 101 is supported by a stand having support legs91 and a handle-sliding track 90. Handle portion 101 comprises anouter-catheter handle 22, a guide-catheter handle 24, animplant-manipulating handle 126, and anchor-release mechanism 28. Handle22 is coupled to a proximal end of outer catheter 12. Handle 24 iscoupled to a proximal portion of guide catheter 14. Handle 126 iscoupled to a proximal portion of reference-force tube 19, and linearmovement of handle 126 with respect to handle 24 moves reference-forcetube 19 (and thereby typically structure 222) through catheter 14. Asdescribed hereinabove, housing 135 of anchor-release mechanism 28 iscoupled to a proximal portion of the tube of anchor driver 36. Therelative positioning of each of the concentrically-disposed componentsof system 10 is shown in the exploded view and sections A-A, B-B, C-C,and D-D of FIG. 2.

The stand supporting proximal handle portion 101 may be moved distallyand proximally to control a position of the entire multi-componentsystem 10, particularly so as to adjust a distance of distal end 102 ofcatheter 12 from the interatrial septum. Handle 22 comprises a steeringknob 210 that is coupled to steering wires 29 a and 29 b disposed withinrespective secondary lumens in the wall of outer catheter 12. Rotationof knob 210 adjusts a degree of tension of wires 29 a and 29 b which, inturn, apply a force to pull ring 11 at the distal end portion of outercatheter 12. Such force steers the distal end portion of catheter 12within the atrium of the heart of the patient in a manner in which thedistal end portion of catheter 12 is steered in a first plane that isparallel with the plane of the annulus of the valve (e.g., in adirection from the interatrial septum toward surrounding walls of theatrium). For some applications of the present invention, the distal endportion of catheter 12 may be pre-shaped so as to point downward towardthe valve. For other applications, the distal end portion of catheter 12may be pulled to assume an orientation in which the distal end portionpoints downward toward the valve. For yet other applications of thepresent invention, the distal end portion of catheter 12 is not made topoint downward toward the valve.

Handle 24 is coupled to track 90 via a first mount 92. Mount 92 isslidable proximally and distally along track 90 in order to control anaxial position of guide catheter 14 with respect to outer catheter 12.Mount 92 is slidable via a control knob 216. For example, control knob216 of mount 92 controls the proximal and distal axial movement of thedistal steerable portion of guide catheter 14 with respect to distal end102 of outer catheter 12. Handle 24 comprises a steering knob 214 thatis coupled to steering wires 31 a and 31 b disposed within respectivesecondary lumens in the wall of guide catheter 14. Rotation of knob 214adjusts a degree of tension of wires 31 a and 31 b which, in turn, applya force to pull ring 13 at the distal end portion of guide catheter 14.Such force steers the distal end portion of catheter 14 in a secondplane within the atrium of the heart of the patient downward and towardthe annulus of the cardiac valve. Typically, as described hereinbelow,the distal end portion of guide catheter 14 is steered in the secondplane that is substantially perpendicular with respect to the firstplane in which the distal end portion of outer catheter 12 is steered.

The combined steering of the respective distal end portions of catheters12 and 14 directs sleeve 26 down toward the annulus (e.g., via thesteering of the distal end portion of catheter 14) and along theperimeter of annulus (e.g., from the posterior section of the valve tothe anterior section of the valve, and vice versa), via the steering ofthe distal end portion of catheter 12.

For some applications, handle 22 may be tilted by the operatingphysician, in order to further adjust a position of the distal end ofcatheter 12.

Handle 126 is coupled to track 90 via a second mount 93. Mount 93 isslidable proximally and distally along track 90, in order to control anaxial position of reference-force tube 19 and at least a proximalportion of sleeve 26 with respect to guide catheter 14. Mount 93 isslidable via a control knob 95. For example, control knob 95 of mount 93controls the proximal and distal axial movement of the tube 19 and atleast the proximal portion of sleeve 26 with respect to distal end 104of guide catheter 14. Taken together with the steering of the distal endportion of guide catheter 14, such movement of tube 19 and at least theproximal portion sleeve 26 moves the proximal portion of sleeve 26toward a desired portion of tissue of the annulus of the valve duringdeployment of anchors 32 from within the lumen of sleeve 26, as isdescribed hereinbelow.

As is described hereinabove, in order to decouple sleeve 26 from aportion of an outer surface of channel 18, (1) channel 18 is pulledproximally, while (2) reference-force tube 19 is maintained in place. Aproximal end of channel 18 is coupled to a knob 94 which adjusts anaxial position of channel 18 proximally and distally with respect toreference-force tube 19 and sleeve 26.

Typically, handle portion 101 comprises a release decision facilitationmember 127, such as a latch or button, that automatically engages when agiven length of sleeve 26 has advanced off channel 18 (e.g., whenchannel 18 is at a given position with respect to tube 19); typicallyjust before sleeve 26 becomes completely decoupled from channel 18.Engagement of member 127 inhibits proximal movement of channel 18 withrespect to tube 19, thereby reducing a likelihood of (e.g., preventing)inadvertent release of sleeve 26. In order to release sleeve 26 (e.g.,to decouple channel 18 from the sleeve), the operating physician mustdisengage member 127, such as by pushing the button, before continuingto withdraw channel 18 proximally. Typically, when engaged, member 127also inhibits distal movement of channel 18 with respect to tube 19.

Handle portion 101 (comprising handles 22, 24, and 126 andanchor-release mechanism 28) has a length L1 of between 65 and 85 cm,e.g., 76 cm. Typically, as shown, a majority of the body portion ofouter-catheter handle 22 is disposed at a non-zero angle with respect toa longitudinal axis 7 of the multiple components of system 10. Thesteering mechanism provided by handle 22 in order to steer the distalend portion of catheter 12 is disposed within the portion of handle 22that is disposed at the non-zero angle with respect to axis 7. Handle 22comprises an in-line tubular portion which is longitudinally disposedin-line along axis 7 and coaxially with respect to handles 24 and 126and release mechanism 28. The in-line tubular portion is shaped so as todefine a lumen for inserting guide catheter 14 therethrough andsubsequently into the lumen of outer catheter 12. The in-line tubularportion has a length L24 of between 7 and 11 cm, e.g., 7 cm. Suchspatial orientation of the majority of handle 22 at an angle withrespect to axis 7 reduces an overall functional length of handle portion101.

Typically, but not necessarily, a guidewire 2244 extends alongsidesleeve 26 to facilitate positioning of sleeve 26 along the annulus.

For some applications, adjustment mechanism 40 is flexibly and/orarticulatably coupled to sleeve 26 (e.g., by being coupled to the sleevevia a suture)

Reference is now made to FIGS. 3A-C, which are schematic illustrationsof annuloplasty ring structure 222, comprising sleeve 26 and adjustmentmechanism 40, in accordance with some applications of the invention. Forsome applications it is advantageous to (1) advance the structure to themitral valve while mechanism 40 is disposed on the longitudinal axis ofsleeve 26 (e.g., collinearly with the sleeve), so as to maintain a smallcross-sectional diameter of the structure for transluminal delivery; and(2) to subsequently move mechanism 40 away from the longitudinal axis,e.g., so as to allow end wall 251 of the sleeve to be placed against theannulus, and/or so as to allow an anchor to be driven through the endwall of the sleeve. Structure 222 facilitates this technique bymechanism 40 being flexibly and/or articulatably coupled to sleeve 26.

Adjustment mechanism 40 of structure 222 is coupled to the lateral wallof sleeve 26 of structure 222, as shown in FIG. 3C. For delivery ofstructure 222, channel 18 is not disposed throughout the entire lumen ofsleeve 26. Rather, a region 3224 (e.g., a distal region) of sleeve 26 isprovided in which channel 18 is not disposed in the lumen of the sleeve,and mechanism 40 is pressed laterally into region 3224, such that thesleeve is compressed at region 3224, and mechanism 40 is disposed on thelongitudinal axis of the sleeve (e.g., collinearly with the sleeve).Typically, region 3224 includes end wall 251 of sleeve 26. It is to benoted, however, that region 3224 may be provided at another positionalong the longitudinal axis of sleeve 26. Typically, mechanism 40 isfixedly coupled to the lateral wall of sleeve 26 at region 3224. In thisstate, structure 222 is disposed within catheter 14 for delivery.

Structure 222 is advanced out of catheter 14. Once at least adjustmentmechanism 40 and/or structure/portion 222 is exposed from catheter 14,the adjustment mechanism moves (e.g., translates) away from thelongitudinal axis of sleeve 26 (e.g., laterally), typically by channel18 being moved distally such that it pushes laterally the portion of thelateral wall of the sleeve to which the adjustment mechanism is coupled(FIG. 3B). FIG. 3C shows channel 18 having been moved all the way todistal end 251 of sleeve 26, and mechanism 40 having been moved awayfrom the longitudinal axis of the sleeve, so as to allow the distal endof the sleeve to be placed against the annulus, and/or so as to allow ananchor to be driven through the distal end wall of the sleeve.

Reference is made to FIGS. 4A-G, which are schematic illustrations ofsteps in the implantation of an annuloplasty ring structure to repair amitral valve, in accordance with some applications of the invention.This procedure is one exemplary procedure that can be performed usingsystem 10.

Annuloplasty ring structure 222 is used to repair a dilated valveannulus of an atrioventricular valve, such as mitral valve 230. For someapplications, the annuloplasty ring is configured to be placed onlypartially around the valve annulus (e.g., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. The annuloplasty ring comprises flexiblesleeve 26 and a plurality of anchors 32. Anchor deployment manipulator61 is advanced into a lumen of sleeve 26, and, from within the lumen,deploys the anchors through a wall of the sleeve and into cardiactissue, thereby anchoring the sleeve around a portion of the valveannulus. For some applications, annuloplasty ring structure 222 isimplemented using techniques described in U.S. application Ser. No.12/437,103, filed May 7, 2009 which published as US 2010/0286767, andwhich issued as U.S. Pat. No. 8,715,342, and/or U.S. application Ser.No. 12/689,635, filed Jan. 19, 2010 which published as US 2010/0280604,and which issued as U.S. Pat. No. 8,545,553, both of which are assignedto the assignee of the present application and are incorporated hereinby reference. As described hereinabove, annuloplasty ring structure 222comprises adjustment mechanism 40. The adjustment mechanism comprises arotatable structure, such as a spool, arranged such that rotation of therotatable structure contracts the implant structure. The implant furthercomprises a longitudinal member, such as a wire, which is coupled to theadjustment mechanism. A rotation tool is provided for rotating therotatable structure. The tool is configured to be guided along (e.g.,over, alongside, or through) the longitudinal member, to engage therotatable structure, and to rotate the rotatable structure in responseto a rotational force applied to the tool.

The procedure typically begins by advancing a semi-rigid guidewire intoa right atrium 220 of the patient. The procedure is typically performedwith the aid of imaging, such as fluoroscopy, transesophageal echo,and/or echocardiography.

The guidewire provides a guide for the subsequent advancement of outercatheter 12 therealong and into the right atrium. Once a distal portionof catheter 12 has entered the right atrium, the guidewire is retractedfrom the patient's body. Catheter 12 typically comprises a 14-24 Fsheath, although the size may be selected as appropriate for a givenpatient. Catheter 12 is advanced through vasculature into the rightatrium using a suitable point of origin typically determined for a givenpatient. For example:

-   -   catheter 12 may be introduced into the femoral vein of the        patient, through an inferior vena cava 223, into right atrium        220, and into a left atrium 224 transseptally, typically through        the fossa ovalis;    -   catheter 12 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        220, and into left atrium 224 trans septally, typically through        the fossa ovalis; or    -   catheter 12 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 220, and into left atrium 224 transseptally,        typically through the fossa ovalis.

For some applications of the present invention, catheter 12 is advancedthrough inferior vena cava 223 of the patient (as shown) and into rightatrium 220 using a suitable point of origin typically determined for agiven patient.

Catheter 12 is advanced distally until the sheath reaches theinteratrial septum, and the guidewire is withdrawn.

A resilient needle and a dilator are advanced through catheter 12 andinto the heart. In order to advance catheter 12 transseptally into leftatrium 224, the dilator is advanced to the septum, and the needle ispushed from within the dilator and is allowed to puncture the septum tocreate an opening that facilitates passage of the dilator andsubsequently catheter 12 therethrough and into left atrium 224. Thedilator is passed through the hole in the septum created by the needle.Typically, the dilator is shaped to define a hollow shaft for passagealong the needle, and the hollow shaft is shaped to define a tapereddistal end. This tapered distal end is first advanced through the holecreated by the needle. The hole is enlarged when the graduallyincreasing diameter of the distal end of the dilator is pushed throughthe hole in the septum. A distal-most end 102 of catheter 12 is taperedso as to facilitate passage of the distal portion of catheter 12 throughthe opening in the septum.

The advancement of catheter 12 through the septum and into the leftatrium is followed by the extraction of the dilator and the needle fromwithin catheter 12. Once the distal portion of catheter 12 is disposedwithin atrium 224, the steerable distal end portion of catheter 12(which includes at least a portion of a bending section 1203) is steeredin a first plane that is parallel to a plane of the annulus of mitralvalve 230. Such steering moves the distal end portion of catheter 12 ina direction from the interatrial septum toward surrounding walls of theatrium, as indicated by the arrow in atrium 224. The steering of thedistal portion of catheter 12 is performed via steering knob 210 ofhandle 22 in handle portion 101 (in FIG. 2).

As shown in FIG. 4A, annuloplasty ring structure 222 with channel 18housing the anchor deployment manipulator 61 (not shown) therein isadvanced through guide catheter 14, which is in turn, advanced throughcatheter 12 into left atrium 224. An exposed distal end portion 114 ofcatheter 14 extends beyond distal end 102 of catheter 12. Exposed distalend portion 114 is then (1) steered toward the annulus of valve 230along a plane that is perpendicular with respect to the steering planeof catheter 12 and that is perpendicular with respect to valve 230, andis (2) bent, via a bending section 1403 toward valve 230. The steeringof the distal portion of catheter 14 is performed via steering knob 214of handle 24 in handle portion 101 (in FIG. 2).

FIG. 4A shows annuloplasty ring structure 222, comprising sleeve 26 andadjustment mechanism 40, having been advanced, via catheter 14, to amitral valve 230. As shown in FIG. 4A, and as described hereinabove,during advancement of structure 222, adjustment mechanism 40 is disposeddistal to (i.e., in front of) sleeve 26. In this way, adjustmentmechanism 40 is disposed on the longitudinal axis of sleeve 26 (e.g.,collinearly with the sleeve), so as to advantageously maintain a smallcross-sectional diameter of the implant for transluminal delivery.Mechanism 40 is typically coupled to sleeve 26 via one or moreconnectors 27, such as sutures, which provide flexible and/orarticulated coupling. A proximal end of connector 27 is disposedproximally to mechanism 40 (e.g., by being fixed to a portion of sleeve26 proximal to mechanism 40 or by being accessible outside the body ofthe patient). A distal end of connector 27 is coupled (e.g., by beingfixedly coupled by a knot or other mechanical coupling) to mechanism 40.Guide member 86, described hereinabove, typically extends distally fromcatheter 14, between end wall 251 of sleeve 26 and adjustment mechanism40, and there is coupled to the adjustment mechanism. For someapplications it is advantageous to (1) advance the structure to themitral valve while mechanism 40 is disposed on the longitudinal axis ofsleeve 26 (e.g., collinearly with the sleeve), so as to maintain a smallcross-sectional diameter of the structure for transluminal delivery; and(2) to subsequently move mechanism 40 away from the longitudinal axis,e.g., so as to allow end wall 251 of the sleeve to be placed against theannulus, and/or so as to allow an anchor to be driven through the endwall of the sleeve. Connectors 27 facilitate this technique by makingmechanism 40 flexibly and/or articulatably coupled to sleeve 26. Forsome applications, connectors 27 are tensioned or relaxed to movemechanism 40 with respect to sleeve 26 to reposition mechanism 40. Forsome applications, guide member 86 is tensioned or relaxed in order toreposition mechanism 40.

For some applications, mechanism 40 is coupled to sleeve 26 in a manneras described hereinabove with reference to FIGS. 1 and 3A-C.

Subsequent to exposure of at least adjustment mechanism 40 (andtypically at least end wall 251 of sleeve 26) from catheter 14, theadjustment mechanism is moved away from end wall 251. Typically, this isachieved by guide member 86 being proximally such that mechanism 40moves (e.g., translates, deflects, and/or rotates) away from thelongitudinal axis of the sleeve, typically to become disposed laterallyfrom sleeve 26. FIG. 4B shows mechanism 40 having translated to such aposition. The movement of mechanism 40 away from end wall 251 of sleeve26 advantageously allows end wall 251 of sleeve 26 to be placed againstan atrial surface of an annulus 240, and a first one of anchors 32 to bedriven through end wall 251 of the sleeve and into the annulus (FIG.4C).

As shown in FIG. 4C, end wall 251 of sleeve 26 is positioned in avicinity of a left fibrous trigone 242 of an annulus 240 of mitral valve230. (It is noted that for clarity of illustration, distal end wall 251of sleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 242 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the distal end of sleeve 26 is positioned in a vicinityof a right fibrous trigone 244 of the mitral valve (configuration notshown). Further alternatively, the distal end of the sleeve is notpositioned in the vicinity of either of the trigones, but is insteadpositioned elsewhere in a vicinity of the mitral valve, such as in avicinity of the anterior or posterior commissure. Once positioned at thedesired site near the selected trigone, deployment manipulator 61deploys the first one of anchors 32 through the wall of sleeve 26 (bypenetrating and passing through the wall of the sleeve in a direction ina direction parallel to a central longitudinal of deployment manipulator61, or anchor driver 36, through the distal end of channel 18, and/orparallel to central longitudinal axis of tissue coupling element 60 ofanchor 32) into cardiac tissue near the trigone. Following thedeployment of anchor 32 in the cardiac tissue, deployment element 38 isdecoupled from anchor 32.

Anchors 32 are typically deployed from a distal end of manipulator 61while the distal end is positioned such that a central longitudinal axisthrough the distal end of manipulator 61 forms an angle with a surfaceof the cardiac tissue of between about 20 and 90 degrees, e.g., between45 and 90 degrees, such as between about 75 and 90 degrees, such asabout 90 degrees. Typically, anchors 32 are deployed from the distal endof manipulator 61 into the atrial surface of the cardiac tissue in adirection parallel to the central longitudinal axis through the distalend of manipulator 61. Such an angle is typically provided and/ormaintained by channel 18 being more rigid than sleeve 26. Distal end 17of channel 18 is typically brought close to the surface of the cardiactissue (and the wall of sleeve 26 that is disposed against the surfaceof the cardiac tissue), such that little of each anchor 32 is exposedfrom channel 18 before penetrating the sleeve and the tissue. Forexample, distal end 17 of channel 18 may be placed (e.g., pushed)against the wall of the sleeve, sandwiching the sleeve against thecardiac tissue.

For some applications, such placement of distal end 17 of channel 18against the cardiac tissue (via the wall of the sleeve), stabilizes thedistal end during deployment and anchoring of each anchor 32, andthereby facilitates anchoring. For some applications, pushing of distalend 17 against the cardiac tissue (via the wall of the sleeve)temporarily deforms the cardiac tissue at the site of contact. Thisdeformation may facilitate identification of the site of contact usingimaging techniques (e.g., by identifying a deformation in the borderbetween cardiac tissue and blood), and thereby may facilitate correctpositioning of the anchor.

That is, the entire circular surface of distal end 17 of channel 18 isdisposed in contact with the wall of sleeve 26 that is disposed againstthe surface of the cardiac tissue. As shown, distal end 17 is thelower-most circular tip of channel 18 and defines a distal opening ofchannel 18. In the configuration in which channel 18 is positioned inorder to sandwich the portion of sleeve 26, the distal end 17 isdisposed in parallel with a planar surface 255 of the tissue of annulus240.

View-A provides an exploded view of components of system 10 isolated inrelative spatial orientation. View-A shows (1) sleeve 26 and distal endwall 251, (2) channel 18 and distal end 17 thereof, and (3) tissue ofannulus 240 at planar surface 255. Deployment manipulator 61 and anchor32 are not shown in View-A for clarity of illustration. View-A shows thealignment of channel 18, specifically distal end 17 thereof, withrespect to distal end wall 251 of sleeve 26, and tissue of annulus 240at planar surface 255. That is, in such an alignment, distal end 17 isaligned substantially in parallel with respect to distal end wall 251 ofsleeve 26, and tissue of annulus 240 at planar surface 255.

Also, for clarity in View-A, distal end 17 of channel 18 is distancedfrom end wall 251, which is distanced from the tissue of annulus 240. Itis to be noted that this distancing is shown by way of illustrationonly, and that during the procedure of implanting anchor 32 into tissueand through wall 251, distal end 17 of channel contacts wall 251, whichcontacts tissue of annulus 240. That is, channel 18 is pushed againstwall 251 such that distal end 17 of channel sandwiches wall 251 betweendistal end 17 and the tissue of annulus 240.

For some applications of the present invention, anchors 32 may bedeployed from a lateral portion of manipulator 61.

As shown in the enlarged image of FIG. 4C, end wall 251 aligns againstthe tissue of annulus 240 in a manner in which a surface of end wall 251is disposed in parallel with a planar surface 255 of the tissue ofannulus 240. Additionally, distal end 17 of implant-decoupling channel18 flattens end wall 251 against the tissue of annulus 240 in a mannerin which channel 18 sandwiches end wall 251 between (1) distal end 17 ofimplant-decoupling channel, and (2) the portion of the tissue of annulus240 at planar surface 255 into which a first one of anchors 32 isimplanted. In such a manner, end wall 251 lies flat against the tissueof annulus 240 in parallel with planar surface 255, while at least adistal portion of tubular side wall 253 is disposed substantiallyperpendicularly with respect to the portion of the tissue of annulus 240at planar surface 255 into which the first one of anchors 32 isimplanted.

As shown, anchor 32 is implanted using channel 18 and manipulator 61contained within sleeve 26 of annuloplasty structure 222 while at leasta portion of annuloplasty structure 222 is contained within surroundingcatheter 14.

Reference is now made to FIGS. 4C and 2. Following the deployment of thefirst tissue anchor, a distal portion of sleeve 26 is decoupled from aportion of implant-decoupling channel 18. In order to decouple theportion of sleeve 26 from outer surface of channel 18, (1) channel 18 ispulled proximally, while (2) reference-force tube 19 is maintained inplace in a manner in which a distal end of tube 19 provides a referenceforce to sleeve 26 in order to facilitate retraction freeing of asuccessive portion of sleeve 26 from around channel 18. In order todecouple sleeve 26 from the outer surface of channel 18, (1) channel 18is pulled proximally, while (2) reference-force tube 19 is maintained inplace. An indicator 2120 on handle 126 provides an indication of howmuch channel 18 is withdrawn from within sleeve 26 (i.e., how much thedelivery tool is decoupled from sleeve 26, and how much the sleeve hasadvanced off channel 18 and against tissue). A proximal end of channel18 is coupled to a knob 94 (FIG. 2) which adjusts an axial position ofchannel 18 proximally and distally with respect to reference-force tube19 and sleeve 26. As shown in FIG. 4D, deployment manipulator 61 isrepositioned along annulus 240 to another site selected for deploymentof a second one of anchors 32.

Reference is now made to FIGS. 2 and 4D. Such repositioning ofmanipulator 61 is accomplished by:

(1) the steering of the distal end portion of catheter 12 (e.g., bysteering knob 210 of handle 22) in the first plane that is parallel withrespect to annulus 240 of valve 230 to a desired spatial orientation andin a manner which bends bending section 1203 of catheter 12,

(2) the steering of the distal end portion of portion of catheter 14(e.g., by steering knob 214 of handle 24) in the second plane that isperpendicular with respect to annulus 240 of valve 230 to a desiredspatial orientation, and in a manner which bends bending section 1405 ofcatheter 14 (specifically bending section 1403),

(3) by axially moving catheter 14 with respect to catheter 12 via knob216,

(4) by axially moving the stand supporting handles 22 and 24 to moveboth catheters 12 and 14,

(5) by moving tube 19 and sleeve 26 axially by sliding mount 93 alongtrack 90 via knob 95, and/or

(6) by moving channel 18 relative to tube 19 by actuating knob 94.

As shown in the enlarged in-phantom image to the right, duringrepositioning of manipulator 61 (i.e., during flexing of theannuloplasty structure 222/sleeve 26 while distal end wall 251 isanchored), a generally-triangular shape is formed between: (1) guidemember 86, (2) a distal end portion 257 of side wall 253 sleeve 26(i.e., the portion of the sleeve that is proximal to end wall 251), and(3) channel 18 surrounded partially by catheter 14. It is to be notedthat the illustrated triangle is shown in phantom to indicate therelative triangular orientation of the three components, and that theillustrated triangle is not a part of the apparatus shown.

Typically, the first tissue anchor is deployed most distally in thesleeve (generally at or within a few millimeters of the distal tip ofthe sleeve), and each subsequent anchor is deployed more proximally,such that the sleeve is gradually decoupled from channel 18 ofdeployment manipulator 61 in a distal direction during the anchoringprocedure (i.e., channel 18 is withdrawn from within sleeve 26, andhandle 126 is moved distally so as to retract the tool to make thesuccessive proximal portion sleeve 26 ready for implantation of asubsequent anchor). The already-deployed first one of anchors 32 holdsthe anchored end of sleeve 26 in place, so that the sleeve is drawn fromthe site of the first tissue anchor towards the site of the secondtissue anchor. As sleeve 26 is drawn and decoupled from channel 18,distal portion 257 of sleeve 26 (i.e., the portion of the sleeve that isproximal to end wall 251) is positioned in a vicinity of tissue ofannulus 240.

Typically, as sleeve 26 is decoupled from channel 18, deploymentmanipulator 61 is moved generally laterally along planar surface 255 ofthe cardiac tissue, as shown in FIG. 4D in a manner which exposes distalportion 257 of sleeve 26 (i.e., the portion of the sleeve that isproximal to end wall 251) and flexes portion 257 to create a generally“U”-shaped portion (i.e., a portion having a concavity with respect totissue of annulus 240 at planar surface 255). Forming portion 257 ofsleeve 26 into the generally “U”-shaped portion (i.e., a portion havinga concavity with respect to tissue of annulus 240 at planar surface 255)comprises creating a gap between portion 257 and the tissue of annulus240 at planar surface 255, the gap having a longest distance D1 between0.2 and 7.5 mm, e.g., 0.5 and 3 mm. Additionally, such forming ofportion 257 is accomplished by flexing portion 257 while end wall 251 isanchored to the tissue of annulus 240. Typically, the gap is formedbetween (1) the tissue of annulus 240 at planar surface 255, and (2) afirst part 258 of the lateral surface distal end portion of side wall253 (i.e., at portion 257). First part 258 is disposed close to thetissue of annulus 240.

Typically, the “U”-shape differs from the natural shape of annulus 240,as it is distanced from the tissue.

Distal end portion 257 has a tubular, lateral surface. Portion 257 isformed into the generally “U”-shaped portion (i.e., a portion having aconcavity with respect to tissue of annulus 240 at planar surface 255)such that first part 258 of the lateral surface of the distal endportion 257 of side wall 253 is formed into a concave surface withrespect to the tissue of annulus 240. For some applications, whenportion 257 is formed into the generally “U”-shaped portion (i.e., aportion having a concavity with respect to tissue of annulus 240 atplanar surface 255), a shape is achieve in which: (1) first part 258,that is concave and disposed closer to the tissue of annulus 240, while(2) a second part 259 of the lateral surface of portion 257 of side wall253 (i.e., opposite first part 258 and father away from the tissue ofannulus 240) is more tensioned and less curved than first part 258. Thatis, first part 258 has (1) a greater degree of curvature than secondpart 259, (2) a smaller degree of tension than second part 259, and (3)a smaller radius of curvature than second part 259. Additionally, secondpart 259 has (1) a smaller degree of curvature than first part 258, (2)a greater degree of tension than first part 258, and (3) a larger radiusof curvature than first part 259.

For some applications, part 258 is crimped or ruffled when portion 257assumes the general “U”-shape.

For some applications, the shape of portion 257 is actively formed byflexing sleeve 26 by deployment manipulator 61. For other applications,the shape of portion 257 is passively assumed during the decoupling ofportion 257 of sleeve 26 from channel 18, positioning of portion 257 ina vicinity of tissue of the annulus, and subsequently, anchoring sidewall 253 to annulus 240 using the second tissue anchor.

FIG. 4D shows distal portion 257 of sleeve 26 (i.e., the portion of thesleeve that is proximal to end wall 251) having been decoupled from aportion of channel 18 by retracting channel 18 proximally. Depending onthe tension applied between the first and second tissue anchor sites,the portion of sleeve 26 therebetween may remain tubular in shape, ormay become flattened, which may help reduce any interference of the ringwith blood flow.

FIG. 4E shows a second tissue anchor 32 (shown as a second tissue anchor32 b) being deployed through a portion of lateral side wall 253 ofsleeve 26. As shown, the first one of anchors 32 deployed through endwall 251 is labeled as anchor 32 a. Deployment manipulator 61 deploysthe second tissue anchor by penetrating and passing through the wall ofsleeve 26 into cardiac tissue at the second site.

As shown, anchor 32 b is implanted using channel 18 and manipulator 61contained within sleeve 26 of annuloplasty structure 222 while at leasta portion of annuloplasty structure 222 is contained within surroundingcatheter 14.

As described hereinabove, anchors 32 a and 32 b are each deployed from adistal end of manipulator 61 while the distal end is positioned suchthat a central longitudinal axis through the distal end of manipulator61 forms an angle with a surface of the cardiac tissue of between about20 and 90 degrees, e.g., between 45 and 90 degrees, such as betweenabout 75 and 90 degrees, such as about 90 degrees. Typically, anchors 32are deployed from the distal end of manipulator 61 into the atrialsurface of the cardiac tissue in a direction parallel to the centrallongitudinal axis through the distal end of manipulator 61. Such anangle is typically provided and/or maintained by channel 18 being morerigid than sleeve 26. Distal end 17 of channel 18 is typically broughtclose to the surface of the cardiac tissue (and the wall of sleeve 26that is disposed against the surface of the cardiac tissue), such thatlittle of anchor 32 b is exposed from channel 18 before penetrating thesleeve and the tissue. For example, distal end 17 of channel 18 may beplaced (e.g., pushed) against the wall of the sleeve, sandwiching thesleeve against the cardiac tissue. Reference is made to FIGS. 4D-E. FIG.4D shows channel 18 of deployment manipulator 61 positioned in alignmentwith a portion of tubular side wall 253 prior to implantation of thenext, consecutive anchor 32 (i.e., 32 b, as shown in FIG. 4E). 4D showsa View-B, which provides an exploded view of components of system 10isolated in relative spatial orientation. View-B shows (1) sleeve 26 anda portion of tubular side wall 253, (2) channel 18 and distal end 17thereof, and (3) tissue of annulus 240 at planar surface 255. Deploymentmanipulator 61 and anchor 32 are not shown in View-B for clarity ofillustration. View-B shows the alignment of channel 18, specificallydistal end 17 thereof, with respect to the portion of tubular side wall253 of sleeve 26, and tissue of annulus 240 at planar surface 255. Thatis, in such an alignment, distal end 17 is aligned substantially inparallel with respect to the portion of tubular side wall 253 of sleeve26, and tissue of annulus 240 at planar surface 255.

Also, for clarity in View-B, distal end 17 of channel 18 is distancedfrom the portion of tubular side wall 253, which is distanced from thetissue of annulus 240. It is to be noted that this distancing is shownby way of illustration only, and that during the procedure of implantinganchor 32 into tissue and through the portion of tubular side wall 253,distal end 17 of channel contacts the portion of tubular side wall 253,which contacts tissue of annulus 240. That is, channel 18 is pushedagainst the portion of tubular side wall 253 such that distal end 17 ofchannel sandwiches the portion of tubular side wall 253 between distalend 17 and the tissue of annulus 240.

As shown in the enlarged image of FIG. 4E, a portion of side wall 253aligns against the tissue of annulus 240 in a manner in which a surfaceof the portion of side wall 253 is disposed in parallel with planarsurface 255 of the surface of the tissue of annulus 240. Additionally,distal end 17 of implant-decoupling channel 18 flattens the portion ofside wall 253 against the tissue of annulus 240 in a manner in whichchannel 18 sandwiches the portion of side wall 253 between (1) distalend 17 of implant-decoupling channel, and (2) the portion of the tissueof annulus 240 at planar surface 255 into which second tissue anchor 32b is implanted. In such a manner, the portion of side wall 253 lies flatagainst the tissue of annulus 240 in parallel with planar surface 255,while the remaining portion of tubular side wall 253 is disposedsubstantially perpendicularly with respect to the portion of the tissueof annulus 240 at planar surface 255 into which second tissue anchor 32b is implanted.

As shown in the right-most, above-view of FIG. 4E, first and secondtissue anchors 32 a and 32 b extend in a substantially same directionand into a common, substantially planar surface 255 of a valve annulus.First and second anchors 32 a and 32 b extend in the substantially samedirection despite that first tissue anchor 32 a is deployed through endwall 251 transverse to side wall 253. That is, first and second anchors32 a and 32 b extend in the substantially same direction while firsttissue anchor 32 a is deployed through end wall 251 transverse to sidewall 253.

As shown in the bottom-left enlarged image, anchors 32 a and 32 b aredeployed consecutively (i.e., in succession with no intervening anchorbetween anchors 32 a and 32 b) and extend in a substantially samedirection. For example, anchors 32 a and 32 b are substantially parallel(e.g., parallel) with respect to each other. For some applications,anchors 32 a and 32 b are disposed with respect to each other at anangle of between 0 and 45 degrees, e.g., between 0 and 30 degrees, e.g.,between 0 and 20 degrees. For some applications, first and second tissueanchors 32 a and 32 b, respectively, are deployed consecutively. Thatis, first and second tissue anchors 32 a and 32 b, respectively, aredeployed in succession with no intervening anchor between anchors 32 aand 32 b, and a distance between anchors 32 a and 32 b is between 2.5and 15 mm, e.g., between 2.5 and 9 mm, e.g., 8 mm.

Reference is now made to FIGS. 4C and 4E. It is to be noted that firstand second tissue anchors 32 a and 32 b are deployed from within thelumen of channel 18 contained within the lumen of sleeve 26, while atleast a proximal portion of sleeve 26 is surrounded by catheter 14, asshown.

Reference is again made to FIG. 4E. As shown, each of anchors 32 a and32 b defines a respective central longitudinal axis 232 a and 232 b.Anchors 32 a and 32 b are substantially parallel (e.g., parallel) withrespect to each other. For some applications, anchors 32 a and 32 b areimplanted with respect to each other such that axes 232 a and 232 b aresubstantially parallel. For some applications, anchors 32 a and 32 b areimplanted with respect to each other such that axes 232 a and 232 b areat angle of between 0 and 45 degrees, e.g., between 0 and 30 degrees,e.g., between 0 and 20 degrees.

For some applications, forming of portion 257 into the generally“U”-shaped portion (i.e., a portion having a concavity with respect totissue of annulus 240 at planar surface 255) comprises anchoring anchor32 b into tissue of annulus 240 at planar surface 255. Anchors 32 a and32 b are implanted in tissue of annulus 240 along a common plane (i.e.,planar surface 255) and extend in substantially the same direction(i.e., anchors 32 a and 32 b extend substantially parallel with respectto each other). First and second anchors 32 a and 32 b extend in thesubstantially same direction despite that first tissue anchor 32 a isdeployed through end wall 251 transverse to side wall 253. That is,first and second anchors 32 a and 32 b extend in the substantially samedirection while first tissue anchor 32 a is deployed through end wall251 transverse to side wall 253.

For some applications, a maximum distance L10 between first tissueanchor 32 a and a point of anchoring of second tissue anchor 32 b isprovided by the length of sleeve 26 that has been decoupled from theportion of channel 18 (e.g., by the distance that channel 18 has beenretracted from sleeve 26, e.g., between 3 and 15 mm, e.g., 8 mm). Thatis, for some applications, second tissue anchor 32 b may be placedanywhere within a circle having a radius that equals L10, centered onthe first tissue anchor.

For some applications, a stiffening element 1926 is provided during theimplantation of sleeve 26, and for some applications, the stiffeningelement facilitates positioning of portions of the sleeve and/or anchors32, such as positioning of subsequent portions and/or anchors followingpositioning of previous portions and/or anchors. For example, and asshown in FIG. 4D, by resisting compression, stiffening element 1926biases the positioning of the distal end of channel 18 (and thereby theposition at which the second tissue anchor will be deployed) toward theperimeter of the circle described hereinabove that is centered on thefirst tissue anchor. That is, by resisting compression, stiffeningelement 1926 biases the second tissue anchor toward being disposed adistance L10 from the first tissue anchor. Due to, or independentlyfrom, this compression-resisting feature of stiffening element 1926,stiffening element 1926 typically maintains an overall length of sleeve26, the length of the sleeve having typically been selected in responseto measurement of the annulus on which it is to be implanted.

By resisting bending, stiffening element 1926 may further bias thepositioning of the distal end of channel 18 (and thereby the position atwhich the second tissue anchor will be deployed) toward a particularsector of the circle. For some applications, by resisting compressionand bending, stiffening element 1926 biases the positioning of thedistal end of channel 18 (and thereby the position at which the secondtissue anchor will be deployed) toward a particular sector of theperimeter of the circle, i.e., toward an arc 1928.

For some applications, by resisting bending, stiffening element 1926biases sleeve 26 (and portions thereof) toward being straight, andthereby biases positioning of the distal end of channel 18 (and therebythe position at which the next anchor will be deployed) toward being ona line defined by at least the two preceding anchors (e.g., the twopreceding anchors define a line segment of the line therebetween). FIG.4E includes a schematic view illustrating first tissue anchor 32 a,second tissue anchor 32 b, and a corresponding portion of sleeve 26having been anchored to annulus 240. A line 1927 is defined by theanchors 32 a and 32 b, stiffening element 1926 (not shown in this view)biasing a subsequent portion of sleeve 26 (and thereby subsequentanchors) to be disposed along line 1927. A desired position of asubsequent anchor is shown by cross 1930. This desired position is atthe annulus, rather than closer to the center of the valve (e.g., theleaflets of the valve). Anatomical constraints and/or application offorce by the operating physician oppose this biasing, such that thesubsequent anchor is anchored at cross 1930. For such applications, thepresence of stiffening element 1926 thereby facilitates placement of thesubsequent anchor at annulus 240, as opposed to placement closer to thecenter of valve 230. It is to be noted that stiffening element 1926biases structure 222 (e.g., sleeve 26 thereof) to assume a shape that isdifferent to that of the native valve and/or native annulus. That is,stiffening element 1926 biases structure 222 (e.g., sleeve 26 thereof)to not conform to the shape of the native valve and/or native annulus.

For some applications, stiffening element 1926 helps maintain the shapeof portion 257. That is, stiffening element 1926 helps maintain thegeneral “U”-shape of portion 257 (i.e., the portion having a concavitywith respect to tissue of annulus 240 at planar surface 255). For someapplications, stiffening element 1926 helps bias portion 257 into theshape. Alternatively, for some applications, the shape of portion 257 asshown in FIG. 4E, is achieved without stiffening element 1926. Forexample, a distal end of stiffening element 1926 is disposed proximallyto portion 257. For other applications, structure 222 does not comprisestiffening element 1926. For some applications, sleeve 26 at at leastportion 257 is resilient.

It is to be noted, however, that stiffening element 1926 is shown by wayof illustration and not limitation, and that for some applications ofthe present invention structure 222 is provided without stiffeningelement 1926.

FIG. 4F shows the entire length of sleeve 26 having been anchored, via aplurality of anchors 32, to annulus 240, as described hereinabove. Asshown, the plurality of remaining anchors 32 are implanted whilemaintaining distal portion 257 of sleeve 26 (i.e., the portion of thesleeve that is proximal to end wall 251) in a generally “U”-shapedportion (i.e., a portion having a concavity with respect to tissue ofannulus 240 at planar surface 255).

The deployment manipulator (i.e., deployment manipulator 61 describedherein but not shown in FIG. 4F) is repositioned along the annulus toadditional sites, at which respective anchors are deployed, until thelast anchor is deployed in a vicinity of right fibrous trigone 244 (orleft fibrous trigone 242 if the anchoring began at the right trigone).Alternatively, the last anchor is not deployed in the vicinity of atrigone, but is instead deployed elsewhere in a vicinity of the mitralvalve, such as in a vicinity of the anterior or posterior commissure.Then, system 10 is removed, leaving behind guide member 86.

FIG. 4G shows an adjustment tool 87 being threaded over and advancedalong guide member 86. Adjustment tool 87 typically comprises a rotationtool, and is configured to actuate (e.g., rotate) adjustment mechanism40, so as to contract contracting member 226, and thereby sleeve 26, asdescribed hereinabove. Typically, adjustment mechanism 40 comprises ahousing which houses a spool, i.e., a rotatable structure, to which afirst end of contracting member 226 is coupled. Typically, the spool isconfigured to adjust a perimeter of annuloplasty ring structure 222 byadjusting a degree of tension of contracting member 226 that is coupledat a first portion of member 226 to the spool. The contracting member226 extends along sleeve 26 and a second portion of contracting member226 (i.e., a free end portion) is coupled to a portion of sleeve 26 suchthat upon rotation of the spool in a first rotational direction, theportion of sleeve 26 is pulled toward adjustment mechanism 40 in orderto contract annuloplasty ring structure 222. It is to be noted that thecontraction of structure 222 is reversible. That is, rotating the spoolin a second rotational direction that opposes the first rotationaldirection used to contract the annuloplasty structure, unwinds a portionof contracting member 226 from around the spool. Unwinding the portionof contracting member 226 from around the spool thus feeds the portionof contracting member 226 back into a lumen of sleeve 26 of structure222, thereby slackening the remaining portion of contracting member 226that is disposed within the lumen sleeve 26. Responsively, theannuloplasty structure gradually relaxes and expands (i.e., with respectto its contracted state prior to the unwinding).

The spool typically comprises a locking mechanism that prevents rotationof the spool after contracting member 226 has been tightened. Forexample, locking techniques may be used that are described withreference to FIG. 4 of U.S. Pat. No. 8,241,351 to Cabiri.

Tool 87 and is used to rotate the spool of adjustment mechanism 40 inorder to tighten structure 222 by adjusting a degree of tension ofcontracting member 226 (not shown in FIG. 4G. Once the desired level ofadjustment of structure 222 is achieved (e.g., by monitoring the extentof regurgitation of the valve under echocardiographic and/orfluoroscopic guidance), rotation tool 87 and guide member 86 are removedfrom the heart. For some applications, a distal portion of guide member86 may be left within the heart of the patient and the proximal end maybe accessible outside the body, e.g., using a port. For suchapplications, adjusting mechanism 40 may be accessed at a later stagefollowing initial implantation and adjustment of ring structure 222.

As shown, sleeve 26 of ring structure 222 comprises a plurality ofradiopaque markers 25, which are positioned along the sleeve atrespective longitudinal sites to indicate anchor-designated targetareas. The markers may provide an indication in a radiographic image(such as a fluoroscopy image) of how much of sleeve 26 has been deployedat any given point during an implantation procedure, in order to enablesetting a desired distance between anchors 32 along the sleeve 26.

Alternatively, annuloplasty ring structure 222 is implanted by right orleft thoracotomy, mutatis mutandis.

For some applications of the present invention, following implantationof sleeve 26 along the annulus, an excess portion of sleeve 26 may bepresent at the proximal portion of sleeve. In such applications,following removal of manipulator 61, a cutting tool (not shown) may beadvanced within channel 18 and into the lumen of the excess portions ofsleeve 26 (e.g., from within sleeve 26) in order to cut the sleeveproximal to the proximal-most-deployed anchor 32.

Reference is again made to FIGS. 4A-G. For anatomical reasons, atransluminal (e.g., transfemoral) approach to the mitral valve viatransseptal puncture typically provides access more directly and/oreasily to the region of the anterior commissure (e.g., including leftfibrous trigone 242) than to the region of the posterior commissure(e.g., including right fibrous trigone 244). It may therefore beadvantageous to position and anchor distal end wall 251 of sleeve 26 inthe vicinity of the left fibrous trigone; the positioning of the firstpoint of anchoring of structure 222 may be more difficult than thepositioning of subsequent points of anchoring (e.g., due to guidanceprovided by sleeve 26 and/or stiffening element 1926; FIG. 4E). Due tothis same reason of accessibility, it may also be advantageous todeliver adjustment tool 87 to the region of the anterior commissure (asshown in FIG. 4G).

System 10 (e.g., structure 222 thereof) is configured to facilitateexploitation of these two advantages: By adjustment mechanism 40 beingdisposed at a distal end of sleeve 26, and being movable away from thelongitudinal axis of the sleeve, (1) the first tissue anchor may bedriven through end wall 251 into the region of the anterior commissure,despite the adjustment mechanism having previously been obstructivelypositioned, and (2) the adjustment tool may be delivered to the regionof the anterior commissure because the adjustment mechanism is disposedin that region.

Reference is made to FIG. 5, which is a schematic illustration of astate of a distal portion of system 10 within the heart of a subject, inaccordance with some applications of the invention. As generallydescribed hereinabove, (i) catheter 12 is steerable in a first plane,(ii) catheter 14 is steerable in a second plane that is typicallyperpendicular to the first plane, and (iii) distal portions of sleeve 26are laid along the annulus of the native valve while proximal portionsof the sleeve (and the distal end of manipulator 61, within the sleeve)are disposed at a nonzero angle with respect to the annulus. Thus,system 10 is configured to assume a multi-bend formation 2948 (e.g.,handle portion 101 is configured to configure catheter 12, catheter 14,and structure 222 to assume the multi-bend formation) in which at leastthree domains 2950, and at least two bends 2952 separating the domains,are defined.

The formation includes (i) a first bend 2952 a that separates a firstdomain 2950 a of the formation from a second domain 2950 b of theformation, and (ii) a second bend 2952 b that separates the seconddomain from a third domain 2950 c of the formation. Typically, theformation further includes a third bend 2952 c that separates firstdomain 2950 a from a fourth domain 2950 d of the formation. First domain2950 a comprises at least (1) part of catheter 12 and (2) part ofcatheter 14 (i.e., at least a part of catheter 14 disposed withincatheter 12), and typically further comprises at least part of sleeve 26(i.e., at least part of sleeve 26 disposed within catheter 14). Seconddomain 2950 b comprises at least part of catheter 14 (e.g., distal endportion 114 thereof), and at least part of sleeve 26 (e.g., the seconddomain comprises at least part of sleeve 26 disposed within a portion ofcatheter 14 that is exposed from catheter 12). Third domain 2950 ccomprises at least part of sleeve 26, and none of catheters 12 or 14(i.e., the third domain comprises part of sleeve 26 that is disposed outof the distal end of catheter 14). In applications in which formation2948 includes third bend 2952 and fourth domain 2950 d, the fourthdomain comprises at least (1) part of catheter 12 and (2) part ofcatheter 14 (i.e., at least a part of catheter 14 disposed withincatheter 12), and may further comprise at least part of sleeve 26 (i.e.,at least part of sleeve 26 disposed within catheter 14). Thus, domains2950 a and 2950 d are typically of similar composition, but separated bythird bend 2952 c.

Thus, handle portion 101 may be considered to be configured:

to drive at least (i) part of catheter 12 and (ii) part of catheter 14to define first domain 2950 a,

to drive at least part of catheter 14 that is disposed outside ofcatheter 12 to define second domain 2950 b,

to drive system 10 to define third domain 2950 c from sleeve 26, and

typically, to drive at least (i) part of catheter 12 and (ii) part ofcatheter 14 to define fourth domain 2950 d.

Reference is made to FIGS. 6A-C, which are schematic illustrations of atissue anchor 2332 configured for anchoring sleeve 26 describedhereinabove, in accordance with some applications of the presentinvention. Anchor 2332 has a coupling head 2310 configured to be coupledto a deployment element 2338, which has a locking mechanism 2128disposed at a distal end thereof. Typically, deployment element 2338(which comprises comprise deployment element 38, described herein) and alocking mechanism 2128. Locking mechanism 2128 is configured toselectively assume locked and unlocked states. When locking mechanism2128 assumes the locked state, the locking mechanism preventsdisengagement of rotating deployment element 2338 from the anchor whichrotating deployment element 2338 currently engages. This locking allowsdeployment element 38 to proximally withdraw anchor 2332 if necessary,without coming disengaged therefrom. Disengagement is thus preventedeven upon withdrawal of the rotating deployment element in the proximaldirection. When the locking mechanism assumes the unlocked state, thelocking mechanism does not prevent disengagement of the rotatingdeployment element from the anchor upon withdrawal of rotatingdeployment element 2338 in the proximal direction. The rotatingdeployment element thus can be disengaged and withdrawn from the anchorin a proximal direction. It is noted that even when the lockingmechanism assumes the unlocked state, the rotating deployment elementgenerally does not disengage from the anchor unless the rotatingdeployment element is withdrawn in the proximal direction.

For some applications, coupling head 2310 is alternatively oradditionally configured to be coupled to, and/or used with, deploymentmanipulator 61, deployment element 38, and/or anchor driver 36 describedhereinabove. Anchor 2332 provides a tissue coupling element 2312 (e.g.,a helical tissue coupling element, as shown, or a screw). For someapplications of the invention, anchor 32 described hereinabove,comprises anchor 2332 and/or anchors 32 and 2332 are interchangeable.

A proximal portion of coupling element 2312 comprises a vertical (andtypically straight) proximal portion 2314 which is coupled to couplinghead 2310 within 3 mm of a central longitudinal axis 2316 of tissueanchor 2332 (e.g., within 1 mm of axis 2316, such as on axis 2316).Proximal portion 2314 may alternatively comprise a proximal stem portionthat couples coupling element 2312 to coupling head 2310. Verticalproximal portion 2314 typically has a length L36 of 0.2-0.7 mm, and istypically more than 1.3 times as great as (e.g., between 2 and 10 timesas great as, such as between 2 and 4 times as great as) a thickness ofthe fabric of sleeve 26. During anchoring of sleeve 26 by anchor 2332(e.g., as shown in FIG. 6B), such a configuration of the positioning ofportion 2314 at the center of coupling head 2310 facilitates rotation oftissue anchor 2332 with respect to sleeve 26 in a manner that preventstwisting of sleeve 26 during rotation. That is, once coupling element2312 has passed far enough through sleeve 26 such that portion 2314traverses the wall of the sleeve (as shown in stage (iii) of FIG. 6B),portion 2314 rotates freely within the wall of the sleeve. (For someapplications in which portion 2314 is coupled to coupling head 2310within 3 mm of, but not on, axis 2316, flexibility of the fabric ofsleeve 26 facilitates such free rotation, by distorting as portion 2314“wiggles”.) Such a configuration allows anchor 2332 to be driven intothe cardiac tissue, such that coupling head 2310 draws sleeve 26 closerto the cardiac tissue, without distorting (e.g., twisting, kinking,buckling, etc.) the sleeve (as shown by the transition from stage (iii)to stage (iv) of FIG. 6B). For some such applications, anchor 2332,coupling element 2312, and/or portion 2314 act as an integral washerand/or a screw with an integral washer, as is known in the hardware art.

Coupling head 2310 may be either male (e.g., a hex or square protrusion)or female (e.g., a straight slot, a hex opening, a Phillips opening, ora Robertson opening). The use of helical anchors, which are screwed intothe cardiac tissue, generally minimizes the force that needs to beapplied during deployment of the anchors into the cardiac tissue. Anchordriver 36 has a deployment element 38 that is either male (e.g.,comprising a screwdriver head, having, such as a slot-head, anAllen-head, a Phillips-head, a Robertson-head, or a hex-head) or female(e.g., comprising a wrench head, having, for example, a square or hexopening), as appropriate for the driving interface provided by couplinghead 2310 of anchor 2332 of FIGS. 6A-C.

Thus, anchor 2332, by way of illustration and not limitation, comprisesa helical portion (i.e., tissue coupling element 2312) and anon-helically shaped portion (i.e., coupling head 2310 and vertical (andtypically straight) proximal portion 2314).

Anchor 2332 has an anchor helix diameter L32 of between 0.2 and 0.3 cm,e.g., 0.25 cm. That is, the radius of the anchor helix from longitudinalaxis 2316 is typically between 0.1 and 0.15 cm, e.g., 0.125 cm. Anchor2332 has an anchor helix pitch L33 of between 0.1 and 0.2 cm, e.g., 0.12cm. Anchor 2332 has an anchor helix length L34 of between 0.3 and 0.6cm, such as 0.3 and 0.45 cm, e.g., 0.35 cm. Anchor 2332 has a helix wirethickness L35 of between 0.02 and 0.1 cm, e.g., 0.05 cm.

For some applications of the invention, torque-limiting apparatus 2300,coupled to anchor driver 36, prevents over-rotation of the anchor,penetration of tissue coupling element 2312 too deep into tissue, and/ordamage to the tissue.

For some applications, a ratio between diameter L32 of the helix ofanchor 2332 (cm) to torque (Ncm) is typically, but not necessarily0.25/0.8, or 0.3125. For some applications, a ratio between pitch L33 ofanchor 2332 (cm) to torque (Ncm) is typically, but not necessarily0.12/0.8, or 0.15. For some applications, a ratio between length L34 ofthe helix of anchor 2332 (cm) to torque (Ncm) is typically, but notnecessarily 0.35/0.8, or 0.4375. For some applications, a ratio betweenthickness L35 of the wire forming anchor 2332 (cm) to torque (Ncm) istypically, but not necessarily 0.05/0.8, or 0.0625.

Typically, but not necessarily, anchor 2332 comprises a biocompatiblematerial such as stainless steel 316 LVM. For some applications, anchor2332 comprises nitinol. For some applications, anchor 2332 is coatedwith a non-conductive material.

Reference is now made to FIG. 7, which is a schematic illustration of astep in the implantation of an annuloplasty ring structure to repair amitral valve, in accordance with some applications of the invention. Itis to be noted that the steps for implanting structure 222 are similarto those described in FIGS. 4A-G and 5 with the exception of portion 257being implanted along the surface of the tissue of annulus 240, whileminimizing or eliminating the gap (defined as having a distance D1)shown in FIGS. 5D-G and 5. As shown in FIG. 7, for some applications,due to the elasticity of the fabric, portion 257 of sleeve 26 isgenerally flush with respect to planar surface 255 of annulus 240despite that first tissue anchor 32 a is deployed through end wall 251transverse to side wall 253 in substantially the same direction (asdescribed hereinabove with reference to FIG. 4E). In such a manner a gapis minimized or eliminated between portion 257 and the tissue of annulus240 at planar surface 255. That is, for some applications, part 258 ofportion 257 is positioned adjacent, alongside, and touching the tissueof annulus 240.

Thus, in such an application of the present invention, structure forms ashape in which: (1) first part 258 of the lateral surface of portion 257of side wall 253, is crimped or ruffled, while (2) second part 259 ofthe lateral surface of portion 257 of side wall 253 (i.e., oppositefirst part 258) is more tensioned and less curved than first part 258.

That is, first part 258 has (1) a higher degree of curvature than secondpart 259, and (2) a smaller radius of curvature than second part 259.Additionally, second part 259 has (1) a smaller degree of curvature thanfirst part 258, (2) a greater degree of tension than first part 258, and(3) a larger radius of curvature than first part 259.

It is to be noted that stiffening element 1926 is shown extendingthrough portion 257 by way of illustration and not limitation. Forexample, for some applications, the shape of portion 257 as shown inFIG. 7, is achieved without stiffening element 1926. For example, adistal end of stiffening element 1926 is disposed proximally to portion257. For other applications, structure 222 does not comprise stiffeningelement 1926. That is, without stiffening element 1926 in portion 257,portion 257 has a greater flexibility to achieve the ruffled and crimpedconfiguration of part 258. For some applications, such flexibility isdue to sleeve 26 comprising a fabric.

Reference is now made to FIGS. 4D-E and 7. As described hereinabove, theshape of portion 257 is achieved in situ actively by flexing sleeve 26prior to deploying the second anchor 32 b. For other applications, theshape of portion 257 is achieved passively in response to releasingportion 257 from channel 18 followed by anchoring wall 253 with secondanchor 32 b.

Reference is made to FIGS. 1-7. It is to be noted that followingimplantation of the annuloplasty structures described herein, thedimensions of the annuloplasty structures may be adjusted remotely andwhile the patient is not on a cardio-pulmonary bypass pump (i.e., with abeating heart), under fluoroscopy and/or echo guidance.

Although annuloplasty structure 222 has been described hereinabove ascomprising a partial annuloplasty ring, in some embodiments of thepresent invention, the ring instead comprises a full annuloplasty ring.

It is to be further noted that system 10 and catheters 12 and 14 may beadvanced using a (1) trans-septal procedure in which the system isadvanced through vasculature of the patient at any suitable accesslocation (e.g., femoral vein), (2) a minimally-invasive transapicalapproach, (3) a minimally-invasive transatrial approach (e.g., anintercostal approach), or (4) a surgical, open-heart approach.Furthermore, for some applications, the systems described herein are notsteerable and may comprise straight elements (e.g., in a surgical,open-heart procedure).

It is to be further noted that system 10 and catheters 12 and 14 forrepairing a dilated annulus of the patient may be used to treat anycardiac valve of the patient, e.g., the aortic valve, the pulmonaryvalve, the mitral valve, and the tricuspid valve. It is to be stillfurther noted that systems described herein for treatment of valves maybe used to treat other annular muscles within the body of the patient.For example, the systems described herein may be used in order to treata sphincter muscle within a stomach of the patient.

It is further noted that the scope of the present invention includes theuse of system 10 and catheters 12 and 14 (or subcomponents thereof) andmethods described hereinabove on any suitable tissue of the patient(e.g., stomach tissue, urinary tract, and prostate tissue).

In some embodiments of the present invention, system 10 is used to treatan atrioventricular valve other than the mitral valve, i.e., thetricuspid valve. In these embodiments, annuloplasty structure 222 andother components of system 10 described hereinabove as being placed inthe left atrium are instead placed in the right atrium. Althoughannuloplasty structure 222 is described hereinabove as being placed inan atrium, for some application the ring is instead placed in either theleft or right ventricle.

Additionally, the scope of the present invention includes embodimentsdescribed in the following applications, which are incorporated hereinby reference. In an embodiment, techniques and apparatus described inone or more of the following applications are combined with techniquesand apparatus described herein:

-   -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec. 22, 2008, which published as US Patent Application        Publication 2010/0161047 and issued as U.S. Pat. No. 8,241,351;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US Patent        Application Publication 2010/0161041 and issued as U.S. Pat. No.        8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US Patent Application        Publication 2010/0286767, and which issued as U.S. Pat. No.        8,715,342;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which published as US Patent Application        Publication 2010/0161042, and which issued as U.S. Pat. No.        8,808,368;    -   PCT Patent Application PCT/IL2009/001209 to Cabin et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on Dec. 22, 2009, which published as PCT        Publication WO 10/073246;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        May 4, 2010, which published as WO 10/128502;    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed on May 4, 2010, which published        as WO 10/128503; and/or    -   PCT Patent Application PCT/IL2012/050451 to Sheps et al.,        entitled, “Controlled steering functionality for        implant-delivery tool,” filed on Nov. 8, 2012, and which        published as WO 13/069019.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1. Apparatus for repairing a cardiac valve, the apparatus comprising: aflexible annuloplasty structure having a sleeve with an elongatedtubular side wall and at least one distal tip; a first tissue anchorpassing through the distal tip of the sleeve; and a second tissue anchorpassing through a section of the tubular side wall, the first and secondtissue anchors are arranged such that: (a) the first and second tissueanchors are disposed with no intervening anchors therebetween; (b) thefirst and second tissue anchors extend in a substantially samedirection; and (c) a longitudinal portion of the tubular side wall isdisposed between the first tissue anchor and the second tissue anchor,and has a first lateral part and a second lateral part opposite thefirst lateral part, the first lateral part being closer to the first andsecond tissue anchors than the second lateral part is to the first andsecond tissue anchors, wherein the second lateral part of thelongitudinal portion has a degree of tension that is larger than adegree of tension of the first lateral part of the longitudinal portion.2. The apparatus according to claim 1, wherein the second tissue anchoris disposed between 0 and 20 degrees with respect to the first tissueanchor.
 3. The apparatus according to claim 1, wherein the second tissueanchor is disposed between 2.5 and 9 mm from the first tissue anchor. 4.The apparatus according to claim 1, wherein the second tissue anchor isdisposed between 0 and 45 degrees with respect to the first tissueanchor.
 5. The apparatus according to claim 1, further comprising anadjustment mechanism configured to adjust a perimeter of the flexibleannuloplasty structure.
 6. The apparatus according to claim 1, furthercomprising a contracting member extending along a length of the sleeve,the contracting member being configured to adjust a perimeter of theflexible annuloplasty structure.
 7. The apparatus according to claim 1,wherein the first and second tissue anchors are disposed consecutivelyand extend in a substantially same direction.
 8. The apparatus accordingto claim 7, wherein the first and second tissue anchors are disposed inparallel.
 9. A system for repairing a cardiac valve, the apparatuscomprising: a flexible annuloplasty structure having a sleeve with anelongated tubular side wall and at least one distal tip; a first tissueanchor passable through the distal tip of the sleeve; and a secondtissue anchor passable through the tubular side wall; wherein the systemis configured to be implantable at the cardiac valve such that a portionof the tubular side wall that is between the first and second tissueanchors assumes a shape in which: the portion has a first part of alateral surface of the tubular side wall and a second part of thelateral surface of the tubular side wall opposite the first part,wherein the second part of the lateral surface of the tubular side wallhas a degree of tension that is larger than a degree of tension of thefirst part of the lateral surface of the tubular side wall.
 10. Thesystem according to claim 9, wherein the second tissue anchor ispositionable between 2.5 and 9 mm from the first tissue anchor.
 11. Thesystem according to claim 9, wherein the second tissue anchor ispositionable between 0 and 45 degrees with respect to the first tissueanchor.
 12. The system according to claim 9, wherein the second tissueanchor is positionable between 0 and 20 degrees with respect to thefirst tissue anchor.
 13. The system according to claim 9, furthercomprising an adjustment mechanism configured to adjust a perimeter ofthe flexible annuloplasty structure.
 14. The system according to claim9, further comprising a contracting member extending along a length ofthe sleeve, the contracting member being configured to adjust aperimeter of the flexible annuloplasty structure.
 15. The systemaccording to claim 9, wherein the first and second tissue anchors areconfigured to be deployed consecutively and extend in a substantiallysame direction.
 16. The system according to claim 15, wherein the firstand second tissue anchors are deployable in parallel.
 17. An system forrepairing a cardiac valve, the apparatus comprising: a flexiblestructure having an elongated tubular side wall; a first tissue anchorconfigured to pass through a first portion of the flexible structure;and a second tissue anchor configured to pass through a second portionof the flexible structure; wherein the system is configured such that,when implanted at the cardiac valve, the tubular side wall between thefirst and second tissue anchors has a first part of a lateral surface ofthe tubular side wall with a degree of tension that is less than alarger degree of tension of a second part of the lateral surface of thetubular side wall opposite the first part.
 18. The system according toclaim 17, further comprising an adjustment mechanism configured toadjust a perimeter of the flexible annuloplasty structure.
 19. Thesystem according to claim 17, further comprising a contracting memberextending along a length of the sleeve, the contracting member beingconfigured to adjust a perimeter of the flexible annuloplasty structure.20. The system according to claim 17, wherein the first and secondtissue anchors are configured to be deployed consecutively and extend ina substantially same direction.